Implantable cardiac device with ischemia response capability

• US 7,774,061 B2
• Filed: 12/23/2005
• Issued: 08/10/2010
• Est. Priority Date: 12/23/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: McCabe, Aaron, Pastore, Joseph M., Zhang, Yi, Lee, Kent, Shuros, Allan C., Brockway, Marina V., Stalsberg, Kevin J.
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): Dietrich; Joseph M
• Application Number:
  US11/318,257
• Publication Number:
  US 20070150015A1
• Time in Patent Office: 1,691 Days
• Field of Search: 607/9, 607/17, 607/18, 607/19
• US Class Current: 607/9
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1102 Ballistocardiography
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A cardiac device is described with the capability of detecting cardiac ischemia using multiple sensing modalities. The device may be configured to modify its behavior in delivering therapies to treat bradycardia or tachyarrhythmias in response to detection of cardiac ischemia.

Claims

1. A cardiac device, comprising:

one or more sensing channels for sensing cardiac activity;

one or more physiological sensors for sensing one or more variables related to cardiac ischemia;

a therapy channel for delivering therapy to the heart;

a controller for controlling the delivery of therapy in response to the sensed cardiac activity; and

,

wherein the controller is programmed to;

collect a plurality of parameters associated with cardiac ischemia from the sensing channels and/or physiological sensors, where the plurality of parameters are designated X₁ through X_n;

compute a vector-valued composite ischemia function that maps the plurality of parameters X₁ through X_n to a vector with a plurality of components designated Y₁ through Y_m that characterize the ischemia by;

performing a regression analysis of historical values of the parameters and episodes of known ischemia, determining weighting coefficients from said analysis for each component of the vector-valued composite ischemia function, and computing each component of the vector-valued composite ischemia function as a weighted sum of one or more of the plurality of parameters using said weighting coefficients; and

,

adjust the manner in which the therapy is delivered by mapping the vector-valued composite ischemia function to a plurality of device behavior modifications designated Z₁ through Z_k.

2. The device of claim 1 further comprising one or more sensing modalities in addition to the one or more sensing channels for measuring or detecting a plurality of parameters associated with cardiac ischemia.

3. The device of claim 1 wherein the controller is programmed to compute at least one component of the composite ischemia function as a numerically-valued function and to compare that component of composite ischemia function with a specified threshold value in order to detect ischemia.

4. The device of claim 3 wherein the controller is further programmed to compute at least one component of the composite ischemia function as a weighted sum of the measured or detected parameters associated with cardiac ischemia.

5. The device of claim 1 wherein the controller is programmed to compare the composite ischemia function with a plurality of specified threshold values corresponding to the components of the vector-valued function in order to detect and characterize the ischemia.

6. The device of claim 5 wherein the controller is programmed to adjust the manner in which therapy is delivered in accordance with the characterization of the ischemia as represented by the vector-valued composite ischemia function.

7. The device of claim 1 further comprising:

an exertion level sensor;

wherein the therapy channel is a pacing channel and the controller is programmed to;

deliver pacing therapy in accordance with a rate-adaptive pacing mode in which a sensed exertion level is mapped to a particular sensor-indicated rate with a rate-response curve and the sensor-indicated rate is limited to a specified maximum sensor-indicated rate; and

,

modify the behavior of the device in delivering pacing therapy upon detection of ischemia by taking one or more actions selected from a group that includes discontinuing rate-adaptive pacing, decreasing the specified maximum sensor-indicated rate, and adjusting a response factor of a rate-response curve so that a particular exertion level is mapped to a lower sensor-indicated rate if cardiac ischemia is detected.

8. The device of claim 1 wherein the therapy channel is a pacing channel for pacing a ventricle and the controller is programmed to:

deliver pacing therapy in accordance with an atrial tracking mode such that a ventricular pace is delivered after expiration of an atrio-ventricular interval without a ventricular sense, the atrio-ventricular interval being started by an atrial sense; and

,

decrease a maximum tracking rate that limits the rate at which ventricular paces can be delivered in response to atrial senses if cardiac ischemia is detected.

9. The device of claim 1 wherein the therapy channel is a pacing channel for pacing a ventricle and the controller is programmed to:

deliver pacing therapy in accordance with an atrial tracking or AV sequential pacing mode such that a ventricular pace is delivered after expiration of an atrio-ventricular interval without a ventricular sense, the atrio-ventricular interval being started by an atrial sense or pace; and

;

decrease the atrio-ventricular interval upon detection of cardiac ischemia.

10. The device of claim 1 wherein the therapy channel is a pacing channel for pacing a ventricle and the controller is programmed to:

deliver pacing therapy in accordance with a specified lower rate limit (LRL); and

,

lower the LRL upon detection of cardiac ischemia.

11. The device of claim 1 wherein the therapy channel is a pacing channel for pacing a ventricle and the controller is programmed to:

deliver pacing therapy with a specified pacing vector; and

,

change the pacing vector upon detection of cardiac ischemia.

12. The device of claim 1 wherein the therapy channel is a pacing channel for pacing a ventricle and the controller is programmed to:

deliver pacing therapy in accordance with a specified lower rate limit (LRL); and

,

initiate or increase hysteresis with respect to the LRL upon detection of cardiac ischemia.

13. The device of claim 1 wherein the therapy channel is a pacing channel and the controller is programmed to:

deliver pacing therapy to a ventricle in accordance with a programmed mode; and

,

switch from a ventricular pacing mode to a non-ventricular pacing mode upon detection of cardiac ischemia.

14. The device of claim 1 wherein the therapy channel is a pacing channel and the controller is programmed to:

deliver pacing therapy to a ventricle in accordance with a programmed ventricular rate regularization mode; and

,

adapt the upper rate of the ventricular rate regularization mode upon detection of cardiac ischemia.

15. The device of claim 1 wherein the therapy channel is a pacing channel and the controller is programmed to:

deliver pacing therapy in accordance with a programmed atrial preference pacing mode; and

,

adapt the upper rate of the atrial preference pacing mode upon detection of cardiac ischemia.

16. The device of claim 1 wherein the therapy channels include a pacing channel and a shock channel for delivering ATP and shock therapy, respectively, and wherein the controller is programmed to:

deliver shock therapy if a tachyarrhythmia above a fibrillation detection rate (FDR) is detected and deliver ATP if a tachyarrhythmia below the FDR is detected; and

, more preferentially deliver shock therapy upon detection of cardiac ischemia by lowering the FDR.

17. The device of claim 1 wherein the therapy channels include a pacing channel and a shock channel for delivering ATP and shock therapy, respectively, and wherein the controller is programmed to:

deliver shock therapy if a tachyarrhythmia above a fibrillation detection rate (FDR) is detected and deliver ATP if a tachyarrhythmia below the FDR is detected; and

,

treat all tachyarrhythmias with shock therapy upon detection of cardiac ischemia.

18. The device of claim 1 wherein the therapy channels include a pacing channel and a shock channel for delivering ATP and shock therapy, respectively, and wherein the controller is programmed to:

deliver shock therapy if a tachyarrhythmia above a fibrillation detection rate (FDR) is detected and deliver ATP if a tachyarrhythmia below the FDR is detected; and

,

modify one or more ATP pacing parameters selected from a group that includes pacing rate, pacing site, and pacing vector upon detection of cardiac ischemia.

19. The device of claim 1 wherein one or more of the parameters associated with cardiac ischemia are selected from a group that includes a detected current of injury in a recorded electrogram, a detected third heart sound, an abnormal heart sound, a detected level of a blood protein marker associated with cardiac ischemia, a detected level of a blood electrolyte associated with cardiac ischemia, a detected level of sympathetic activity as computed from heart rate variability, an oxygen content of the blood as sensed by an oximeter, abnormal heart wall motion as sensed by a wall motion sensor, and a hemodynamic parameter that can be affected by cardiac ischemia as may be measured by a pressure, cardiac impedance, or flow sensor.

20. A method, comprising:

sensing cardiac activity;

delivering therapy to the heart in response to the sensed cardiac activity;

sensing a plurality of parameters associated with cardiac ischemia;

collecting a plurality of parameters associated with cardiac ischemia from the sensing channels and/or physiological sensors, where the plurality of parameters are designated X₁ through X_n;

computing a vector-valued composite ischemia function that maps the plurality of parameters X₁ through X_n to a vector with a plurality of components designated Y₁ through Y_m that characterize the ischemia by;

performing a regression analysis of historical values of the parameters and episodes of known ischemia, determining weighting coefficients from said analysis for each component of the vector-valued composite ischemia function, and computing each component of the vector-valued composite ischemia function as a weighted sum of one or more of the plurality of parameters using said weighting coefficients; and

,

adjusting the manner in which the therapy is delivered by mapping the vector-valued composite ischemia function to a plurality of device behavior modifications designated Z₁ through Z_k.

21. The method of claim 20 wherein the parameters associated with cardiac ischemia include a parameter derived from the sensed cardiac electrical activity and a parameter derived using one or more additional sensing modalities.

22. The method of claim 20 further comprising computing at least one component of the composite ischemia function as a numerically-valued function and comparing that component of the composite ischemia function with a specified threshold value in order to detect ischemia.

23. The method of claim 22 further comprising computing at least one component of the composite ischemia function as a weighted sum of the measured or detected parameters associated with cardiac ischemia.

24. The method of claim 20 further comprising comparing the composite ischemia function with a plurality of specified threshold values corresponding to the components of the vector-valued function in order to detect and characterize the ischemia.

25. The method of claim 24 further comprising adjusting the manner in which therapy is delivered in accordance with the characterization of the ischemia as represented by the vector-valued composite ischemia function.

26. The method of claim 20 further comprising:

delivering pacing therapy in accordance with a rate-adaptive pacing mode in which a sensed exertion level is mapped to a particular sensor-indicated rate with a rate-response curve and the sensor-indicated rate is limited to a specified maximum sensor-indicated rate; and

,

modifying the behavior of the method in delivering pacing therapy upon detection of ischemia by taking one or more actions selected from a group that includes discontinuing rate-adaptive pacing, decreasing the specified maximum sensor-indicated rate, and adjusting a response factor of a rate-response curve so that a particular exertion level is mapped to a lower sensor-indicated rate if cardiac ischemia is detected.

27. The method of claim 20 further comprising:

delivering pacing therapy in accordance with an atrial tracking mode such that a ventricular pace is delivered after expiration of an atrio-ventricular interval without a ventricular sense, the atrio-ventricular interval being started by an atrial sense; and

,

decreasing a maximum tracking rate that limits the rate at which ventricular paces can be delivered in response to atrial senses if cardiac ischemia is detected.

28. The method of claim 20 further comprising:

delivering pacing therapy in accordance with an atrial tracking or AV sequential pacing mode such that a ventricular pace is delivered after expiration of an atrio-ventricular interval without a ventricular sense, the atrio-ventricular interval being started by an atrial sense or pace; and

;

decreasing the atrio-ventricular interval upon detection of cardiac ischemia.

29. The method of claim 20 further comprising:

delivering pacing therapy in accordance with a specified lower rate limit (LRL); and

,

lowering the LRL upon detection of cardiac ischemia.

30. The method of claim 20 further comprising:

delivering pacing therapy with a specified pacing vector; and

,

changing the pacing vector upon detection of cardiac ischemia.

31. The method of claim 20 further comprising:

delivering pacing therapy in accordance with a specified lower rate limit (LRL); and

,

initiating or increasing hysteresis with respect to the LRL upon detection of cardiac ischemia.

32. The method of claim 20 further comprising:

delivering pacing therapy to a ventricle in accordance with a programmed mode; and

,

switching from a ventricular pacing mode to a non-ventricular pacing mode upon detection of cardiac ischemia.

33. The method of claim 20 further comprising:

delivering pacing therapy to a ventricle in accordance with a programmed ventricular rate regularization mode; and

,

adapting the upper rate of the ventricular rate regularization mode upon detection of cardiac ischemia.

34. The method of claim 20 further comprising:

delivering pacing therapy in accordance with a programmed atrial preference pacing mode; and

,

adapting the upper rate of the atrial preference pacing mode upon detection of cardiac ischemia.

35. The method of claim 20 further comprising:

delivering shock therapy if a tachyarrhythmia above a fibrillation detection rate (FDR) is detected and delivering ATP if a tachyarrhythmia below the FDR is detected; and

,

more preferentially delivering shock therapy upon detection of cardiac ischemia by lowering the FDR.

36. The method of claim 20 further comprising:

delivering shock therapy if a tachyarrhythmia above a fibrillation detection rate (FDR) is detected and deliver ATP if a tachyarrhythmia below the FDR is detected; and

,

treating all tachyarrhythmias with shock therapy upon detection of cardiac ischemia.

37. The method of claim 20 further comprising:

delivering shock therapy if a tachyarrhythmia above a fibrillation detection rate (FDR) is detected and deliver ATP if a tachyarrhythmia below the FDR is detected; and

,

modifying one or more ATP pacing parameters selected from a group that includes pacing rate, pacing site, and pacing vector upon detection of cardiac ischemia.

38. The method of claim 20 further comprising increasing the shock energy used to deliver shock therapy upon detection of cardiac ischemia.

39. The method of claim 20 wherein one or more of the parameters associated with cardiac ischemia are selected from a group that includes a detected current of injury in a recorded electrogram, a detected third heart sound, an abnormal heart sound, a detected level of a blood protein marker associated with cardiac ischemia, a detected level of a blood electrolyte associated with cardiac ischemia, a detected level of sympathetic activity as computed from heart rate variability, an oxygen content of the blood as sensed by an oximeter, abnormal heart wall motion as sensed by a wall motion sensor, and a hemodynamic parameter that can be affected by cardiac ischemia as may be measured by a pressure, cardiac impedance, or flow sensor.